As we head into the new week, here’s a quick summary of major data security developments from around the country.
Aetna Hit With Second “Envelope” Lawsuit -
Aetna Inc. is now facing a second lawsuit over the disclosure...more

Recently, the D.C. Circuit Court of Appeals ruled in Attias v. CareFirst, Inc., No. 16-7108, that customers had standing to sue a health insurer for a 2014 data breach in which the customers’ information was stolen. ...more

Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion. Not...more

The U.S. Court of Appeals for the D.C. Circuit has held that allegations of a heightened risk of future identity theft resulting from a data breach established a concrete injury at the pleading stage....more

We have previously reported on the evolving circuit split over standing in data breach class actions. On August 1st, a three judge panel for the District of Columbia Circuit became the latest to weigh in on the issue. In...more

The FDA cannot get out of its own way on the issue of off-label communications. Its power to punish off-label promotion comes from an odd regulatory two-step, whereby off-label promotions are said to prove an indicated use...more

There’s a problem with attorney advertising in the prescription medical product space – but it’s not the one you normally hear us defense-side litigators kvetching about. Quite apart from its litigation-generating effects,...more

More than once we’ve said that we read law review articles so you don’t have to. We separate the wheat from the chaff. The wheat is scarce. That is because law review articles usually drown the little bits of objective...more

This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue...more

Last week we bashed a Ninth Circuit Daubert decision. We feel a little bit bad about that, not because the decision wasn’t bashworthy – no, Wendell really is a rotten precedent – but because we hate contributing to the...more

Now that Dr. Scott Gottlieb is safely installed as FDA Commissioner, we at DDLaw can end our moratorium on blogposts about First Amendment issues. There was no way we wanted to give his opponents any ammunition by saying nice...more

Prior to the end of the previous Administration, FDA released several draft guidance documents and a white paper addressing different types of communications about medical products. On January 18, 2017, FDA published two...more

As 2017 began, FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices. The Agency had hosted a public hearing in November 2016 to...more

From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible....more

On the eve of a change in administration, the U.S. Food and Drug Administration (FDA or the Agency) released a flurry of documents regarding off-label communications and FDA’s ability to regulate such communications within...more

On January 18, 2017, the Food and Drug Administration (“FDA”) released three key documents outlining the agency’s current thinking regarding drug and device manufacturers’ communication of information not contained in...more

The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

This guest post is from Liz Minerd, an associate at Reed Smith. She previously wrote the post on the FDA’s off-label promotion meeting last November, so when she indicated that she’d like to write about the FDA’s “Midnight...more

On January 18, 2017, the Food and Drug Administration (FDA or the Agency) released for public comment a Memorandum, Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding...more

The U.S. Court of Appeals for the Third Circuit has vacated a district court's dismissal of a data breach class action filed against Horizon Healthcare Services Inc., in the wake of the 2013 theft of two computer laptops...more

The United States Supreme Court today granted certiorari in Bristol-Myers Squibb Co. v. Superior Court. Here is a link to the order. The California Supreme Court decision in this case was our worst case for all of 2016. ...more

Many people and news outlets have opined, weighed in, and informed the public about the 2015 Anthem breach. It is still a hot topic in January 2017, because it currently lines up with other hot stories about hacking ordered...more

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